CN1220132A - Body fluid sampling device - Google Patents

Body fluid sampling device Download PDF

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Publication number
CN1220132A
CN1220132A CN98122671A CN98122671A CN1220132A CN 1220132 A CN1220132 A CN 1220132A CN 98122671 A CN98122671 A CN 98122671A CN 98122671 A CN98122671 A CN 98122671A CN 1220132 A CN1220132 A CN 1220132A
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sleeve
ring
sampling device
surface
device according
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CN98122671A
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Chinese (zh)
Inventor
布伦特·G·迪雄
杰弗里·N·罗
理夏德·拉德万斯基
乔尔·S·道格拉斯
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莫克里诊断公司
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Priority to US08/975,978 priority Critical patent/US5964718A/en
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Publication of CN1220132A publication Critical patent/CN1220132A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188Constructional features of reusable driving devices
    • A61B5/15192Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing
    • A61B5/15194Constructional features of reusable driving devices comprising driving means, e.g. a spring, for retracting the lancet unit into the driving device housing fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150015Source of blood
    • A61B5/150022Source of blood for capillary blood or interstitial fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150053Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150061Means for enhancing collection
    • A61B5/150099Means for enhancing collection by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150412Pointed piercing elements, e.g. needles, lancets for piercing the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381Design of piercing elements
    • A61B5/150503Single-ended needles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150541Breakable protectors, e.g. caps, shields or sleeves, i.e. protectors separated destructively, e.g. by breaking a connecting area
    • A61B5/150549Protectors removed by rotational movement, e.g. torsion or screwing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/15058Joining techniques used for protective means
    • A61B5/150618Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150694Procedure for removing protection means at the time of piercing
    • A61B5/150717Procedure for removing protection means at the time of piercing manually removed
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15103Piercing procedure
    • A61B5/15107Piercing being assisted by a triggering mechanism
    • A61B5/15111Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15101Details
    • A61B5/15115Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
    • A61B5/15117Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/151Devices specially adapted for taking samples of capillary blood, e.g. by lancets, needles or blades
    • A61B5/15186Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
    • A61B5/15188Constructional features of reusable driving devices
    • A61B5/1519Constructional features of reusable driving devices comprising driving means, e.g. a spring, for propelling the piercing unit
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/15Devices for taking samples of blood
    • A61B5/150007Details
    • A61B5/150374Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150633Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves

Abstract

把环放在皮肤上,并重复地对环作用弹性压力,可从皮肤切口采集体液,由此,环的刺激器表面挤压切口周围的一圈皮肤和身体组织,使体液从切口压出。 The ring is placed on the skin and reproducibly effect resilient pressure ring, the body fluid can be collected from the skin incision, thereby pressing the stimulator surface of the ring circle skin and body tissue surrounding the incision, the pressure causes the body fluid from the incision. 刺激器表面的倾斜角为10到65度;刺激器表面的宽度从5mm到20mm,刺激器表面的内径不小于6.0mm。 The inclination angle of the stimulator surface is from 10 to 65 degrees; width of the stimulator surface is from 5mm to 20mm, an inner diameter of the stimulator surface is not less than 6.0mm.

Description

体液采样装置 A body fluid sampling device

本发明涉及了从人体获得血液和其它液体采样、供分析或处理用的穿刺装置和方法。 The present invention relates to a sample to obtain blood and other fluids from the body for analysis or puncturing apparatus and method for processing.

在目前使用中的许多医疗程序需要极少量的、在5到50微升范围内的血样。 In currently used in many medical procedures require a very small amount of blood in the range of 5-50 microliters. 在所选部位上,如手指上采用穿刺方法来收集1滴或2滴血液,它与采用静脉切开来抽取一管静脉血相比,对病人来说,花费更合理和所受创伤更少。 On the selected portions, such as using finger puncture method to collect a drop or 2 drops of blood, and uses it to extract a phlebotomy blood as compared to patients, it takes a more rational and less trauma suffered. 随着家用化验,如自检血糖的出现,需要一种简单的程序,可由需要化验的人员在任何设施中完成。 With home testing, such as the emergence of the self-test blood sugar, it requires a simple procedure may be needed in any laboratory personnel to complete the facility.

通常使用的刺血针一般具有一个刚性本体和一根从一端突出的消毒针。 The lancet commonly used generally have a rigid body and a sterile needle projecting from one end. 刺血针可用于穿刺皮肤,由此可从所产生的开口收集血样。 The lancet may be used to pierce the skin, whereby blood samples were collected from the resulting opening. 把血液送到化验设备或收集设备。 The blood to the test device or collection device. 最普通是从指尖采血,那里的供血一般是很好的。 The most common is blood from the fingertip, where the blood supply is generally good. 但是,在该区的神经密度使许多病人感到明显的疼痛。 However, the nerve density in this region for many patients feel significant pain. 有时可在其它部位,如耳垂和四肢上采样,以进入不太敏感的部位。 Sometimes on other parts of the sample, such as earlobes and limbs, is less sensitive to enter the site. 但这些部位不易提供良好的血样,并难以把血液直接送到化验设备。 But these parts is not easy to provide a good blood, and the blood is difficult to directly assay device.

在有限表面积(如手指)上重复穿刺会形成硬结。 Induration repeated puncture formed on a limited surface area (e.g., a finger). 这将增加抽血困难和增加疼痛。 This will increase blood difficulties and increased pain.

为了减少对穿刺皮肤和相应疼痛的担心,已开发了许多弹簧加载装置。 In order to reduce the fear of puncturing the skin and corresponding pain, we have developed a number of spring-loading means. 以下两份专利代表了在80年代开发的、用于家用诊断化验产品上的装置。 The following two patents represent a device on the home diagnostic tests for product development in the 1980s.

Cornell等的美国专利号4,503,856描述了一个弹簧加载的刺血针注射器。 Cornell, etc. U.S. Patent No. 4,503,856 describes a lancet spring loaded syringe. 这个重复使用的装置与易处理的刺血针对接。 This device is reusable and disposable lancet for connection. 刺血针架可锁定在退出的位置上。 The lancet holder may be locked in the exit position. 当使用者接触一个释放装置时,一个弹簧使刺血针以高速穿刺皮肤,然后退出。 When the user contacts a release means, a spring causes the lancet to puncture the skin at high speed, and then exit. 为了减少与针刺相应的疼痛,速度是很重要的。 In order to reduce the pain and the corresponding needle, the speed is very important.

Levin等的美国专利号4,517,978描述了一个血液采样装置。 Levin et al U.S. Patent No. 4,517,978 describes a blood sampling device. 该装置也是用弹簧加载,采用了标准的易处理的刺血针。 The device is also spring loaded, it uses a standard lancet tractable. 该设计可容易和精确地对手指定位,因而易于确定穿刺部位。 The design can be easily and accurately positioned finger, thus easily puncture site is determined. 在刺血针穿刺皮肤之后,回弹的弹簧使刺血针退到装置内的安全位置上。 After the lancet needle of the skin, the rebound spring causes the lancet to retreat to a safe position within the device.

在公共设施中,往往希望从病人收集到采样,然后以可控制的方式把采样送到化验装置中。 In public facilities, it is often desirable to collect the sample from the patient, then a controlled manner in the sample to the assay device. 例如,某些血糖检测系统需要把血样送到与化验仪器连接的化验装置中。 For example, some systems require the blood glucose testing device connected to the test laboratory instrument. 此时,把病人手指直接放到化验装置中会造成从先前病人血液得到感染的危险。 At this point, the finger of a patient directly into the assay device will get dangerous infections from the previous patient's blood. 对于这种系统,特别是在医院设施中,通常穿刺一个病人皮肤,通过毛细作用把采样收集在一个小型吸管内,然后把采样从吸管送到化验装置中。 For such a system, especially in hospital settings, it is used to puncture a patient's skin, the samples collected via capillary action within a small pipette, and then the sample from the pipette to the test device.

Haynes的美国专利号4,920,977描述了采用具有刺血针和小型收集管的血液收集装置。 Haynes U.S. Patent No. 4,920,977 describes a blood collection device uses a lancet and having a small collection tube. 该装置把刺血针和收集容器结合成单个装置。 The apparatus of the lancet and collection container are combined into a single device. 穿刺和收集是两个分开的动作,但如果希望在使用前收集采样,该装置是一个方便而易处理的单个装置。 Lancing and collection are two separate actions, but if desired the sample collection prior to use, the device is a convenient single unit easily understood process. 相似的装置公开在Sarrine的美国专利号4,360,016和O'Brien的美国专利号4,924,879中。 Sarrine similar device is disclosed in U.S. Patent No. 4,360,016 and U.S. Patent No. 4,924,879 to O'Brien in.

Jordan等的美国专利号4,850,973和4,858,607公开了一种组合装置,它可根据不同构造,交替地用作注射器式的注射装置和带有易处理的实心刺血针的穿刺装置。 Jordan et al. U.S. Pat. Nos. 4,850,973 and 4,858,607 disclose a combination device which may be configured according to different, alternately as a syringe-type injection device and a lancing device with disposable solid needle lancet is.

Lange等的美国专利号5,318,584描述了一个血液穿刺装置,用于诊断时的抽血。 Lange et al U.S. Patent No. 5,318,584 describes a blood lancing device for blood at the time of diagnosis. 该发明采用了一个转动/滑动传递系统,以减少穿刺时的疼痛。 This invention uses a rotary / sliding transmission system to reduce the pain upon puncturing. 使用者可容易和精确地调节穿刺深度。 The user can easily and precisely adjust the penetration depth.

Suzuki等的美国专利号5,368,047,Dombrowski的美国专利号4,654,513和Ishibashi等的美国专利号5,320,607均描述了吸入式采血器。 Suzuki et al U.S. Patent No. 5,368,047, Dombrowski U.S. Patent No. 4,654,513 and Ishibashi et U.S. Patent No. 5,320,607 both describe inhaled blood collection. 当穿刺皮肤后、刺血针保持机构退出时,这些装置在穿刺部位和装置端部之间产生吸入作用。 When the skin is punctured, the lancet holding mechanism when the exit, the device generates a suction effect between the lancing site and the end of the device. 在从穿刺部位抽取适当采样或使用者从装置上退出之前,围绕装置端部的一个柔性垫有助于穿刺部位四周端部的密封。 Before extracting the appropriate sample from the puncture site or the user exits from the apparatus, a flexible pad around the end of the device helps seal the end portion of the puncture site four weeks.

Garcia等的美国专利号4,637,403和Haber等的美国专利号5,217,480公开了组合的穿刺和血液收集装置,它们采用一个薄膜来建立受创部位的真空。 Garcia et al. U.S. Patent No. 4,637,403 and Haber et U.S. Patent No. 5,217,480 discloses a blood lancing and collection device combination thereof to create a vacuum using a film hit site.

Erickson等的美国专利号5,582,184描述了一个收集和测量体液的装置。 Erickson et al U.S. Patent No. 5,582,184 describes a means of collecting and measuring body fluids. 该系统采用了放在一个分隔元件内的同轴注射器和毛细管。 The system uses a coaxial syringe and capillary tube is placed a spacer element. 分隔元件限制了注射器的穿刺深度,并在注射器留在皮肤内时压缩注射器周围的身体组织,以改进间质液到切口的流动。 Spacer member limits the penetration depth of the syringe and leave the syringe body tissue compressed around the syringe while the skin, to improve the flow of interstitial fluid incision. 但是,可以理解到,切口有闭合注射器的趋势,因而限制了可达到的任何优点。 However, it will be appreciated that the tendency incision closed syringe, thereby limiting any advantage that can be achieved.

对于单用的化验,如家用胆甾醇化验,以及对于公共场所使用,也开发了单用的装置,以消除许多病人使用时的交叉感染。 For a single laboratory use, such as home cholesterol testing, and for public places, it has also been developed with a single device, to eliminate cross-infection of many patients. Crossman等的美国专利号4,869,249和Swierczek的美国专利号5,402,798也公开了易处理的单用的穿刺装置。 Crossman et U.S. Patent No. 4,869,249 and U.S. Patent No. 5,402,798 Swierczek also discloses a single disposable lancing device.

作为侵入采样的替代方式,美国专利号5,421,816;5,445,611和5,458,140公开了采用超声的泵吸作用,直接从原有(无穿刺)皮肤挤出间质液。 As an alternative to invasive sampling, U.S. Patent Nos. 5,421,816; 5,445,611 and 5,458,140 disclose the use of the pumping action of ultrasound, extrusion interstitial fluid directly from the original (non-puncture) skin. 但用该法获得的液量是十分有限的。 But the amount of fluid obtained by this method is very limited.

上述发表的专利均结合在这里作为参考。 Above published patents incorporated herein by reference.

即使已作了许多改进,穿刺造成的疼痛对许多病人仍是个重要的问题。 Even though many improvements have been made, the pain caused by the puncture of many patients remains a significant problem. 对于数百万糖尿病患者,采血的需要和对相应疼痛的恐惧也是一个主要的障碍,由于疼痛,他们不能适当地检测他们的血糖。 For millions of diabetics, and also requires a major obstacle to appropriate pain fear of blood, due to pain, they can not properly test their blood sugar. 此外,用穿刺来得到血样对其它诊断应用已更加普遍,需要有一种更少疼痛、最少侵入的装置来提高这些应用程度,并使这些技术更加得到接受。 In addition, a blood sample is obtained by puncturing of other diagnostic applications have become more common, a need for a less painful, least invasive means to improve the extent of these applications, and these techniques more accepted.

所以,本发明的目的是提供一种装置和方法,以通过皮肤得到体液的采样,它实际上没有疼痛和极少侵入。 Therefore, an object of the present invention is to provide an apparatus and method for sampling bodily fluid obtained through the skin, it is actually no pain and very little invasion.

此外,已有的穿刺装置包括手动的按钮,一旦使用者把装置放在皮肤上,就可击发刺血针驱动机构。 Moreover, conventional lancing device comprises a manual button, once the user places the device on the skin, can drive the lancet firing mechanism. 由于使用者知道激发刺血针的精确时刻,因而在击发瞬时使用者有突然抬高装置的倾向,这可能造成不一致的皮肤穿刺,或者可能没有穿刺。 Because the user knows the precise moment that the excitation of the lancet, thus firing the user tends to sudden instantaneous elevation of the apparatus, which may cause inconsistent skin puncturing, pricking or may not. 所以,本发明的另一个目的是提供一种穿刺装置,它可消除使用者方面的这种倾向。 Therefore, a further object of the present invention is to provide a lancing device which eliminates such a tendency part of the user.

另外,已有的支承易处理刺血针的支座形式是容许刺血针通过其下端单独地插入和卸下。 Further, the carrier has the form of a disposable lancet support is to allow the lancet individually be inserted and removed through the lower end thereof. 为了把它向上推或向下拔,需要使用者握住刺血针的下部。 In order to push up or pull it down, requiring the user to hold the lower portion of the lancet. 由于针头从从刺血针下端突出,使用者的手靠近针头,因而有可能受到伤害和/或感染。 Since the needle from protruding from the lower end of the lancet, a user's hand close to the needle, and thus there may be harmed and / or infection. 还有,刺血针通常是靠摩擦配合保持在支座中。 Also, the lancet is usually held by a friction fit in the seat. 由于常规的制造公差,很难保证刺血针有足够的紧密配合;因而刺血针有晃动的倾向,由此在穿刺过程中增加了所受的疼痛感觉。 Since conventional manufacturing tolerances, the lancet is difficult to ensure a sufficient tight fit; therefore the lancet tends to sway, thereby increasing the perception of pain suffered during lancing.

因此,本发明的另一个目的是提供一个消除上述缺点的刺血针支座。 Accordingly, another object of the present invention is to eliminate the above drawbacks to provide a lancet holder.

本发明的另一个目的是提供一种方法,它可根据采样的部位和所穿刺的深度,取得血液或间质液的采样。 Another object of the present invention is to provide a method which can be based on the sampling location and depth of the puncture, to obtain samples of blood or interstitial fluid. 尽管目前没有利用间质液(ISF)装置的商品,但可主动设法建立在ISF中的分析物,如葡萄糖与整个血液比较的关系。 Although there is no use of interstitial fluid (ISF) means commodity, but may actively seek to establish, such as the relationship with the whole blood glucose compared analyte in ISF. 如果很易得到ISF,并建立了上述关系,最好把ISF作为一种采样,因为它没有红血球的干扰或调节血球比率的需要。 If ISF is readily available, and to establish the relationship described above, as a preferable the ISF sampling, because it does not interfere with red blood cells or hematocrit adjustment required.

本发明的另一个目的是提供一种方法,它抽取少量但可调节的采样,如合适的话,一个化验装置为3微升,另一个化验装置为8微升。 Another object of the present invention is to provide a method, which extracts a small but adjustable sample, as appropriate, of a 3 microliter assay device, the assay device further 8 microliters.

本发明涉及了一种采集血液或间质液的采样装置。 The present invention relates to a sampling device for collecting blood or interstitial fluid. 装置包括:一个确定纵轴的可手握的套筒,一个适于支承皮肤穿刺工具、如刺血针或激光器、在皮肤上产生切口的支座,以及一个从套筒纵向前端突出并相对于套筒作纵向运动的环。 Apparatus comprising: determining a longitudinal axis of the sleeve can be hand, adapted to support a skin puncture tool, such as a lancet or laser holder nicking the skin, and a distal end projecting from the sleeve with respect to the longitudinal the sleeve for longitudinal movement of the ring. 环具有一个适于与皮肤表面接触的前刺激器表面。 Ring having a front stimulator surface adapted to contact with the skin surface. 一个可弹性变形的传力件有效地放在套筒和环之间,把力从套筒传到环,以响应套筒相对于环的向前运动,把刺激器表面压到皮肤表面上。 A force transmitting member can be effectively elastically deformable ring placed between the sleeve and, the forces to the ring from the sleeve in response to forward movement of the sleeve relative to the ring, to press the stimulator surface to the skin surface. 刺激器表面的形状可压住皮肤切口周围的皮肤和身体组织的环形区,使切口鼓起和切口四周打开,由此把体液从切口压出。 Stimulator surface shape may be pressed against the skin surrounding the skin incision and the annular region of body tissue, so that the incision to bulge and the sides of the incision to open, whereby body fluid is forced from the incision. 装置也可以省去支座,由此用单独的装置来完成穿刺。 Support means may also be omitted, whereby a separate device to complete the piercing.

最好是,装置的所有零件是单件,并且装配在一起时不用单独的紧固件。 Preferably, all parts of the apparatus is a single piece and assembled together without a separate fastener.

环最好构成一个内环,而装置还包括围绕着内环可伸缩的外环。 An inner ring configuration preferably, the apparatus further comprising surrounding the inner telescopic outer ring. 外环从套筒向外突出,相对于套筒可作纵向运动。 Projecting outwardly from the outer sleeve, the sleeve may be made with respect to the longitudinal movement. 一个弹簧弹性地把外环向前偏压。 A spring resiliently biases the outer ring forwardly. 外环相对于套筒和内环均可沿纵向运动。 The outer ring and the inner ring relative to the sleeve can be movable longitudinally.

本发明也涉及了一种装置,它具有一个相对于与轴线垂直的平面为倾斜的刺激器表面。 The present invention also relates to a device having a phase of the stimulator surface is inclined relative to a plane perpendicular to the axis. 倾斜是沿径向向内和沿纵向向后。 It is inclined radially inwardly and longitudinally rearwardly. 相对于平面的倾斜角为10到65度。 Angle of inclination with respect to the plane is from 10 to 65 degrees. 刺激器表面的宽度最好约5mm到约20mm。 The width of the stimulator surface is preferably from about 5mm to about 20mm. 刺激器表面的内径最好不小于6.0mm。 The inner diameter of the stimulator surface is preferably not less than 6.0mm.

从以下参照附图对优选实施例的详细描述,本发明的目的和优点将会变得很明显,图中相同数字表示相同的零件,其中:图1是本发明采样装置的侧视图;图2是本发明针头组件的纵向剖面图,易处理针已装在其中;图3是采样装置外壳件的前透视图;图4是图3外壳的纵向剖面图;图5,6和7均是针头组件的分解透视图;图8是针头组件外环件的后透视图;图9是本发明采样装置的撞击组件的分解透视图;图10是撞击组件和图3外壳的分解透视图;图11是采样装置外壳和套筒件的分解透视图;图12是整个采样装置的分解透视图;图13A-13I均是采样装置的纵向剖视图,描述了它工作顺序。 From the following detailed description of embodiments with reference to the accompanying drawings of the preferred embodiments, objects and advantages of the invention will become apparent, the same numerals in FIG like parts, wherein: FIG. 1 is a side view of the sampling device of the present invention; FIG. 2 is a longitudinal sectional view of a needle assembly of the present invention, the disposable needle is mounted therein; FIG. 3 is a front perspective view of the sampling device housing member; FIG. 4 is a longitudinal sectional view of the housing of FIG. 3; FIG. 5, 6 and 7 are the needle an exploded perspective view of the assembly; FIG. 8 is a rear perspective view of the needle assembly of the outer ring member; FIG. 9 is an exploded perspective view of a striker assembly of the sampling device of the invention; FIG. 10 is an exploded perspective view of the striker assembly 3 and the casing; FIG. 11 it is an exploded perspective view of the device housing and the sleeve member of the sample; FIG. 12 is an exploded perspective view of the entire sampling means; FIG. 13A-13I are longitudinal sectional view of a sampling device, describing its working order.

附图(如参见图1和图13A)中所示的一个最小侵入采样装置10包括了一个管状套筒12,一个管状外壳14可伸缩地装在其中。 BRIEF (e.g., see FIG. 1 and FIG. 13A) shown in a minimally invasive sampling device 10 comprises a tubular sleeve 12, a tubular housing 14 telescopically mounted therein. 套筒12和外壳14确定了公共的纵向轴线A。 Sleeve 12 and housing 14 determine a common longitudinal axis A. 外壳14包括一个前开口,可容纳一个可拆卸的刺血针针头组件16(也可参见图2),它用于支承一个易处理的刺血针部件15(以下简称“易处理针”),并刺激皮肤的穿刺部位,以下将作说明。 A housing including a front opening 14, can receive a detachable lancet tip assembly 16 (see also FIG. 2), which is used to support the lancet member 15 of a disposable (hereinafter referred to as "disposable needle"), and stimulate the skin puncture site, as will be explained.

装在外壳14内还有:一个沿穿刺皮肤方向向前移动易处理针的撞击件18,一个把撞击件向后退回到击发准备(即向前受压)位置的手动把手20,以及使上述零件获得适当运动的许多弹簧。 14 there is mounted in the housing: a forward movement in the direction of skin puncture disposable needle striking member 18, the striking member to a retracted back to a cocked (i.e., pressed forward) position of the manual handle 20, and so that the appropriate access to many parts of the spring movement.

针头组件16包括一个内环22、一个外环24、一个连接套26、一个外环弹簧28、一个支座30和一个支座弹簧32。 Needle assembly 16 comprises an inner ring 22, an outer ring 24, a coupling sleeve 26, an outer ring spring 28, a carrier 30 and a spring seat 32. 内环22包括一个基本上为空心的圆柱体,靠近其前端具有沿径向向外突出的法兰34,在其后端具有一对向后突出的安装腿36。 The inner ring 22 comprises a substantially hollow cylinder, near its distal end having a radially outwardly projecting flange 34 at its rear end with a pair of rearwardly projecting mounting legs 36. 每条腿36包括一个相对与轴线A倾斜的倒角后表面38,每个表面38形成一个具有面朝前肩部40的钩子。 Each leg 36 includes a relatively oblique to the axis A of the chamfered rear surface 38, each surface 38 forming a hook having a forwardly facing shoulder 40. 内环的面朝前表面42相对于轴线为倾斜,其原因在以下将作更详细的说明。 Facing the front surface of the inner ring 42 is inclined relative to the axis for reasons that will be explained in more detail.

外环24包括一个基本上为圆柱的空心体,在其外缘具有沿周向间隔的凹槽46,如后面将说明,这可使使用者更容易转动针头组件16。 The outer ring 24 comprises a substantially cylindrical hollow body having on its periphery circumferentially spaced grooves 46, as will be explained later, this allows the user to more easily needle assembly 16 is rotated. 由于将讨论的原因,外环24的内表面上具有轴向槽47(图8)。 For reasons to be discussed, the outer ring having an axial slot 47 (FIG. 8) on the inner surface 24. 如后面将讨论,外环24的面朝前表面48相对于轴线A为倾斜。 As will be discussed later, facing the front surface 48 of the outer ring 24 relative to the axis A is inclined. 在底面48之后相隔开的位置上,外环24上设有一个沿径向向内突出的法兰50。 Spaced apart position after the bottom surface 48, an outer ring 24 provided with a radially inwardly projecting flange 50.

内环22适于与外环24的内部作同轴配合,并使外环弹簧28安放在法兰50上。 Inside the inner ring 22 is adapted to fit the outer ring 24 in coaxial, and the outer ring spring 28 seated on the flange 50.

支座30适于与内环22的内部配合,并使支座弹簧32安放在内环内部面朝后的肩部52上。 Inner support 30 is adapted to mate with the inner ring 22, and a spring seat 32 seated on a shoulder 52 facing the inside of the inner ring. 设在支座30后端上的径向外法兰54靠在支座弹簧后端上。 Rear seat 30 provided on the radially outer abutment flange 54 rests on the rear end of the spring.

支座30的内表面下端的直径缩小,它形成底座56,易处理针15通过支座上端向前插入后靠在底座上。 The inner diameter of the lower end of the support surface 30 is reduced, which forms the base 56, after the disposable needle is inserted through the upper end 15 forward against the seat base.

易处理针15可采用任何希望的形式,但最好是包括一个围绕金属刺血针53模制的单件塑料件。 Disposable 15 may take any desired form of a needle, but preferably comprises a single piece of plastic around a metal lancet needle 53 molded. 塑料件大致为X形截面,由四个朝后呈锥形的肋片55形成,由此肋片55前端靠在支座30的底座56上。 Plastic parts substantially X-shaped cross section, is formed by the post 55 is tapered toward the four ribs, whereby the ribs 55 on the support base 56 against the distal end 30. 塑料件也可包括一个整体模制的帽57(参见图13C),在易处理针已装在针头装置16之后,可把它拧断,以露出刺血针53(图13D)。 The plastic member may also include an integrally molded cap 57 (see FIG. 13C), the disposable needle after the needle has been installed in the device 16, it can be twisted off to expose the lancet 53 (FIG. 13D).

连接套26包括一个柱形的开槽裙部60,它可伸缩地配合在外环内。 26 comprises a cylindrical connection sleeve slotted skirt 60 which fits telescopically within the outer ring. 裙部60包括轴向肋片62,它配合在外环24的槽47内,把外环和连接套锁定在一起转动。 The skirt 60 includes axial ribs 62 which fit within the groove 24 of the outer ring 47, the outer ring and the connecting sleeve rotatably locked together. 在其上端,连接套26包括一个面朝后、沿径向向内突出的肩部64(参见图13B),它在连接套26卡到内环22的腿36上时,支承腿36的肩部40。 At its upper end, comprises a connecting sleeve 26 rearwardly facing, radially inwardly projecting shoulder 64 (see FIG. 13B), it is connected to the inner sleeve 26 the card 22 between the legs 36, 36 of the shoulder support leg 40.

在连接套后端设有沿径向向外突出的法兰结构,它具有一对沿直径相对、面朝前的肩部70(一个肩部70如图7所示),肩部相对于轴线A为倾斜。 It is provided with radially outwardly projecting flange structure connected to the rear end of sleeve, for having a pair of diametrically opposed, forwardly facing shoulders 70 (one shoulder 70 shown in FIG. 7), with the shoulder axis A is inclined. 肩部70最好沿一般的螺旋线延伸。 Shoulder 70 preferably extends along a generally helical line. 在两个肩部70之间沿周向有一对沿径向向外突出、面朝后的肩部72(一个肩部72如图7所示),它也相对于轴线A为倾斜,例如,沿着与肩部70路线成轴向偏置的螺旋线延伸。 Between the two shoulders 70 along the circumferential direction with a pair of radially outwardly, rearwardly facing shoulders 72 (one shoulder 72 shown in FIG. 7), which is also inclined relative to the axis A, e.g., the shoulder 70 extends along a line offset axially helix. 因此在肩部70、72之间形成了沿直径相对的轴向间隙74(一个间隙74如图7所示),使连接套可装到外壳14上,这将在下面说明。 Thus between the shoulders 70, 72 formed in a diametrically opposed axial gap 74 (one gap 74 shown in FIG. 7), the connecting sleeve may be attached to the housing 14, which will be described below.

外壳14是基本上为空心管状,并包括直径比其后区82大的前区80(参见图3和4)。 A substantially hollow housing 14 is tubular, and comprises a subsequently larger than the diameter region 82 front region 80 (see FIGS. 3 and 4). 前区的后端包括一对直径相对的锁定凸耳84(参见图4)。 The rear end of the front region comprises a pair of diametrically opposed locking lugs 84 (see FIG. 4). 在连接套26插入外壳14的下区80之后,凸耳84位于连接套面朝后的肩部72之后(如图7所示),在图12中顺时针方向转动连接套可使连接套的面朝前的肩部70与相关凸耳84的顶面配合,使连接套26和外壳14沿轴向收缩并锁定在一起,实际上是依靠螺纹形式的连接。 After the coupling sleeve 26 is inserted into the lower zone 80 of the housing 14, lug 84 is connected to the shoulder 72 after the sleeve facing (7), rotatably connecting sleeve allow connecting sleeve 12 in the clockwise direction of FIG. forward-facing shoulder 70 associated with the top surface of the lug 84 with the connecting sleeve 26 and the housing 14 is axially contracted and locked together, in fact, depend on the form of a threaded connection.

外壳14还包括一个具有面朝前肩部92的弹性指状件90(图4),用于与套筒12内表面上的面朝后肩部94(图13A)配合,以保持外壳14在套筒12内的位置。 The housing 14 further includes a forwardly facing shoulder portion 92 having resilient fingers 90 (FIG. 4), for engaging the shoulder 94 (FIG. 13A) on the facing inner surface of the sleeve 12, the housing 14 in order to maintain position within the sleeve 12. 此外,外壳14包括一个锁定凸耳96,它相对于外壳14后区82的后面部分,沿径向向外隔开,如图13A所示。 Further, the housing 14 includes a locking lug 96, which portion 14 relative to the rear region of the rear housing 82, spaced radially outwardly, as shown in FIG. 13A. 该锁定凸耳96可在套筒12内表面上纵向锁定槽98内滑动,并布置成可保持撞击件18处于击发准备状态。 The locking lug 96 is longitudinally slidable within the locking grooves 98 on the inner surface of the sleeve 12, and arranged to be held in the hammer 18 cocked state.

撞击件18滑动地装在外壳14内,并具有一个前支承面100和一对具有钩子的后安装臂102,钩子的形状使得可依靠卡紧配合,与在外壳内滑动安装的保持套104成为锁定(参见图9和13A)。 Striking member 18 slidably mounted within the housing 14, and has a front bearing face 100 and a pair of rear mounting arms having a hook 102, the shape of the hook makes it possible to rely on clamping fit, and in the housing slidably mounted retaining sleeve 104 is locked (see FIG. 9 and 13A). 撞击件18还包括一个锁定指状件106,它具有面朝前的肩部108,布置成当撞击件在击发准备状态时与外壳14的锁定凸耳96配合。 The impact member 18 further comprises a locking finger 106, having a forward-facing shoulder 108, arranged such that when the striker 96 with the locking lug when a cocked state with the housing 14. 锁定指状件106可在锁定槽98内滑动而防止撞击件的转动。 Locking finger 106 to prevent rotation of the slidable impinging member 98 in the lock groove.

按钮20的舌片111通过外壳14后端内的后开口110向前延伸。 Button 11120 tongue extends forwardly within the rear end of the rear housing 14 through the opening 110. 舌片111包括一对弹性腿112。 Tongue 111 includes a pair of resilient legs 112. 弹性腿112的前端形成钩子114,它布置成与装在撞击件18外缘上的圈环120前端相配合。 Elastic leg distal end 112 forms a hook 114, which is arranged to mate with the front end mounted on the outer periphery 18 of the impact member 120 rings.

按钮弹簧122作用在保持套104和圈环120之间,而撞击件弹簧124作用在外壳14后面和保持套104之间。 Holding the button spring 122 acts between the sleeve 104 and the rings 120, 124 and hammer spring 14 acts between the rear retaining sleeve 104 and the housing. 套弹簧126作用在套筒12的面朝前肩部128和外壳14的面朝后肩部130之间。 Between the sleeve shoulder 130 spring 126 acting upon the front face 128 and downward facing shoulder 14 of the housing sleeve 12.

一个定位件132(图12,13A)卡在外壳14的凹槽134内。 A positioning member 132 (FIG. 12, 13A) card within the recess 134 of the housing 14. 定位件132具有一个向后直径变小的中心孔136,万一采样装置10前端朝上时,用于防止易处理针15向后移动(参见图13C)。 The positioning member 132 has a central bore 136 rearwardly of reduced diameter, in case the front end of the sampling device 10 upwards, for preventing the disposable needle 15 is moved backward (see FIG. 13C).

为了装配上述装置,把内环22插入外环24中和把外环弹簧28放在内环22上,由此首先把针头组件16的零件装在一起。 To assemble the above-described apparatus, the inner ring 22 is inserted into the outer ring 24 and the outer spring 28 on the inner ring 22, whereby the first part of the needle assembly 16 assembled together. 然后,把支座弹簧32放在内环22内,并把连接套26卡在内环的腿36上。 Then, the carrier spring 32 is placed within the inner ring 22, the connecting sleeve 26 and card 36 on the inner leg.

把圈环120在撞击件18上滑动,并把按钮弹簧122插在撞击件上,由此装配主体部分。 The annular ring 120 slides on the striking member 18, the button and the spring 122 is inserted in the striking member, thereby fitting the body portion. 然后把保持套104卡在撞击件18的安装臂102上,以限定它们之间的按钮弹簧122。 Then the retaining sleeve 104 in the card mounting arm 102 of the impact member 18 to define the knob spring 122 therebetween. 然后把撞击件弹簧124插在保持套104上。 The hammer spring 124 is then inserted in the holding sleeve 104.

然后把装好的撞击分组件105插入外壳14内(参见图10),其中锁定指状件106对准锁定槽98。 Then packed impact subassembly 105 is inserted into the housing 14 (see FIG. 10), wherein the locking finger 106 aligned with the locking groove 98. 然后把套筒弹簧126和套筒12放到外壳上,通过外壳后开口110把按钮20插入,使得其弹性腿112通过保持套104和按钮弹簧122,并卡在圈环120内。 Then the sleeve 126 and the sleeve spring 12 into the housing, the housing 20 is inserted through the rear opening button 110, such that the resilient leg 104 and the sleeve 112 by holding the button spring 122 and snap ring 120 within a collar.

把定位件132插入外壳14的凹槽134内,把针头组件16向后装入外壳内,直到外壳的锁定凸耳84与连接套的肩部72配合为止。 The positioning member 132 is inserted into the recess 134 of the housing 14, the needle rearwardly within the housing assembly 16 is loaded, until the locking lug 84 and the connecting sleeve 72 with a shoulder of the housing so far. 然后,转动针头组件(依靠外环24的转动),使得锁定凸耳84沿周向通过相关的间隙74(参见图7)。 Then, rotation of the needle assembly (by virtue of rotation of the outer ring 24), such that the locking lugs 84 circumferentially through an associated gap 74 (see FIG. 7). 连接套的肩部26盖在凸耳84上,并把针头组件紧固在外壳内。 Connecting sleeve shoulder lugs 26 on the lid 84, and the needle assembly secured within the housing.

为了使用该装置,在图7中反时针方向转动外环24和连接套26,取下针头组件16,通过支座30后面把一个易处理针15向前插入。 To use the device, is rotated in the counterclockwise direction in FIG. 7 of the outer ring 24 and adapter 26, remove the needle assembly 16, the seat back 30 by a disposable needle 15 is inserted forwardly. 然后,重新安装针头组件(图13C),用手拧断易处理针的帽57(图13D),使刺血针53露出。 Then, re-install the needle assembly (FIG. 13C), the disposable hand twisting off the needle cap 57 (FIG. 13D), so that the lancet 53 is exposed.

然后向后拔出按钮20,使撞击件18向后拔(图13D)。 Button 20 is then pulled back, so that the impact member 18 rearward pull (FIG. 13D). 撞击件的锁定指状件106通过锁定凸耳96向上移动。 Striking the locking finger member 106 by a locking lug 96 is moved upward convex. 此时,按钮弹簧122和撞击件弹簧124均受压缩。 At this time, the knob spring 122 and hammer spring 124 are subject to compression. 由此释放按钮20,按钮弹簧122向前拉按钮20,以及撞击件弹簧124向前推撞击件,直到锁定指状件的肩部108靠到锁定凸耳96为止(图13E)。 Whereby the release button 20, the button spring 122 pulled forward button 20, striker spring 124 and striker is pushed forward until the locking shoulder 108 against the fingers up to the locking lug 96 (FIG. 13E). 现在撞击件处于击发准备状态。 Now the striker is in a cocked state.

现把外环24的前表面48放在使用者的皮肤S上,使用者握住套筒12,把套筒12推向使用者的皮肤S。 Now the front surface 48 of the outer ring 24 is placed on the user's skin S, the user holds the sleeve 12, the sleeve 12 toward the user's skin S. 因此,外环24相对于内环22向后移动,使外环弹簧28受压缩。 Thus, the outer ring 24 moved rearward relative to the inner ring 22, outer ring so that the spring 28 is compressed. 这一直到内环22的前表面42与皮肤表面S配合为止(图13F)。 The inner ring 22 until the front surface of the fitting 42 until the skin surface S (FIG. 13F). 对套筒12的进一步向下力使套筒12相对于外壳14作向前移动。 Further downward force on the sleeve 12 causes the sleeve 12 moves forward relative to the housing 14 for. 此时,由套筒12的内表面区150与锁定指状件106配合并向内推,由此锁定指状件106从从锁定凸耳96上释放。 In this case, by the inner surface area of ​​the sleeve 12 and the locking fingers 150 of member 106 and the push fitting, thereby locking finger 106 is released from the locking lug 96. 这使得预先压缩的撞击件弹簧124把撞击件18向前移到易处理针15的后端(图13G),由此易处理针与支座30一起向前移动,使支座弹簧32受压缩。 This enables the pre-compressed hammer spring 124 to move the impact member 18 forward tractable rear (FIG. 13G) needle 15, whereby the disposable needle holder 30 moves forward together with the carrier spring 32 is compressed . 当易处理针15向前移动时,刺血针53穿刺皮肤表面并在那里形成切口I,此后支座弹簧32立即使支座30和易处理针15退回(图13H)。 When the disposable needle 15 moves forwardly, the lancet 53 punctures the skin surface and form where the incision I, carrier spring 32 immediately after the support pin 30 and tractability 15 retracted (FIG. 13H).

作用在套筒12的向前力通过压缩的套筒弹簧126、外壳14和连接套26传到内环22。 The forward acting force of the compression sleeve 12 by the sleeve spring 126, the housing 14 and inner ring 22 connected to sleeve 26 passes. 因此内环22的前表面42挤压切口I周围皮肤和身体组织的环形区,使切口鼓起,并舒展切口的四周。 Thus the front surface 22 of the inner ring 42 and pressing the skin around the incision I in body tissue annular region, so that the incision to bulge and stretch cut four weeks. 因此,如血液或间质液的液体F由挤压的身体组织和皮肤收集和加压,使得它通过鼓起切口的开口向上移动。 Accordingly, as the liquid blood or interstitial fluid F from an extruded skin and body tissue collected and pressurizing, so that it moves upwardly through the slit opening muster. 也就是说,挤压的皮肤和身体组织环形圈限制了液体向外流出。 That is to say, squeezing the skin and body tissues annular ring restricts the outward flow of liquid.

当套筒12上的向前力释放时(图13I),套筒弹簧126使套筒退回,使得内环22作用在皮肤上的力得到释放。 When the forward force on the sleeve 12 is released (FIG. 13I), the sleeve spring 126 to return the sleeve, so that the force 22 acting on the inner skin to be released. 因此,切口I的四周闭合,新鲜的液体(原先被挤压的皮肤和身体组织阻塞)流向切口,以替代已经从切口压出的液体。 Thus, the sides of the incision I close, fresh fluid (previously extruded skin and body tissue blocking) to the incision to replace the liquid has been pressed out from the incision. 当对套筒以及内环再作用向前力时(参见图13H),上述动作被重复,通过切口向上压出补充的液体。 When (see FIG. 13H) and the forward force on the inner sleeve reworking, the above operation is repeated, the liquid pushed out by the upward cutouts complementary. 最后,这个“泵吸”作用形成了能被采样的大小适当的体液滴B。 Finally, this "pumping" action of forming droplets of a suitable size that can be sampled B.

虽然所说明的内环22的前面一般为环形,但也可以是其它形状,如椭圆或多边形,由此挤压出的身体组织圈为相似的形状。 Although the foregoing described the inner ring 22 is generally annular, but may be other shapes, such as oval or polygonal, whereby the extruded body tissue ring of a similar shape.

为了得到最多的可回收体液流,已经确定了内环22的前面,即刺激器表面42的某些最佳的尺寸特性。 In order to obtain a maximum flow of recoverable body fluid, in front of the inner ring 22 has been determined, i.e., the stimulator surface of some of the best characteristics of size 42. 对此,相对于与轴线A垂直的平面P,面42的倾角α应为从约10度到约65度,最好为25到65度(参见图13F)。 In this regard, with respect to a plane P perpendicular to axis A, the inclination angle α of surface 42 should be from about 10 degrees to about 65 degrees, preferably 25 to 65 degrees (see FIG. 13F). 面42的宽度W(即内环外径减去内环内径)应从约5mm到约20mm。 The width W of the surface 42 (i.e. the outer diameter minus the inner ring inner diameter) should be from about 5mm to about 20mm. 表面42的内径应不小于6.0mm,并不大于12.0mm。 Inner diameter surface 42 is not less than 6.0mm, and not more than 12.0mm. 由于刺激器表面42的倾斜角在上述α角范围内,可保证该表面排出充足的体液流到切口。 The inclination angle of the stimulator surface 42 within the above angular range α, which ensures adequate fluid flow to the surface of the discharge slit. 由于内径不小于6.0mm,表面42不会与采样适当尺寸(即3微升)的血滴B接触和把它抹掉。 The inner diameter not less than 6.0mm, the contact surface 42 does not sample blood drop B of suitable size (i.e., 3 microliters) and to erase it.

由于通过弹性传力件,即套筒弹簧126把向前的“泵吸”力从套筒12作用到内套上,在套筒12相对于外壳14向前运动时,作用力有延长的停顿期。 Since by the elastic force transmission member, i.e., the sleeve spring 126 forward "pumping" force from the sleeve to the action of the sleeve 12, when the forward movement of the sleeve 12 relative to the housing 14, the biasing force has a prolonged pause period. 这使得限制在切口I周围的更多血液或层间质液从切口向上推出。 This restriction makes the interstitial fluid from the slit between the upwardly and blood or more layers around the incision I.

除了针53和弹簧28、32、122、124和126外,采样装置10的零件最好由塑料制成。 In addition to needle 53 and the springs 28,32,122,124 and 126, replacement of the sampling device 10 is preferably made of plastic. 所有塑料零件均是单件结构(即避免把各部分胶接成一个零件)。 All plastic parts are single-piece structure (i.e., avoiding the portions glued to a part). 此外,所有塑料零件不用单独的紧固件连接在一起,而采用卡紧连接或螺纹连接(如连接套26与外壳14的连接)。 In addition, all plastic parts are connected together without a separate fastener, while the use of clamping or screwing connections (such as connections 26 connecting sleeve 14 of the housing). 这大大地简化了采样装置的构造和降低了制造成本。 This greatly simplifies the construction of the sampling device and to reduce the manufacturing cost.

可以理解到,采样装置10提供了撞击件的自动击发来响应装置对皮肤的挤压。 It will be appreciated that the sampling device 10 provides automatic firing striking member in response to the pressing device to the skin. 这消除了使用者在击发时刻突然抬起装置的任何可能,因为使用者不知道击发的时刻,同时保证了从一次穿刺操作到下一次操作完成同样的穿刺深度。 This eliminates any potential users in the firing moment suddenly raised his device, because the user does not know the time of the firing, while maintaining the same penetration depth from one operation to the next puncture operation is completed.

通过针头组件16上端装卸易处理针的能力说明,使用者可保持他或她的手远离刺血针。 Capacity disposable needle assembly 16 through the needle upper handling instructions, the user can keep his or her hands away from the lancet. 这保证了避免偶然的伤害,可能是受到污染刺血针的伤害。 This ensures against accidental damage, could be hurt contaminated lancet. 由易处理针四个突起55确定的易处理针在支座内的四点固定,建立了易处理针在支座内稳定不动的安装。 A disposable needle four projections 55 defined in the disposable needle is fixed four-point bearing, the disposable needle is mounted to establish the stable fixed in the support. 因此,在穿刺过程中易处理针不会侧向运动,由此减少了使用者承受的疼痛感。 Thus, in the process of the disposable lancing needle without lateral movement, thereby reducing the pain of the user to bear.

采样装置把血液或间质液之类体液泵吸到皮肤表面的能力使装置可用于在身体上对疼痛不太敏感的部位,如在耳朵部位皮肤的穿刺。 It means the ability of a blood sample or interstitial fluid and the like bodily fluid pumped into the skin surface of the device may be used on the body portion less sensitive to pain, such as the skin puncture site in the ear.

虽然结合优选实施例描述了本发明,熟悉该技术的人员可以理解到,可作出尚未具体描述的补充、修改、替代和删除,而不背离所附权利要求所规定的本发明精神和范围。 While the embodiments described in connection with preferred embodiments of the present invention, a person skilled in the art to be appreciated, has not been specifically described may be supplemented, modifications, substitutions and deletions without departing from the spirit and scope of the invention as defined in the appended claims.

Claims (23)

1. 1. 一种采集血液或间质液的采样装置,装置包括:一个确定纵轴的可手握的套筒;一个适于支承皮肤穿刺工具在皮肤上产生切口的支座;一个从套筒纵向前端突出并安装成相对于套筒作纵向运动的环,环具有一个适于与皮肤表面接触的前刺激器表面;以及一个可弹性变形的传力件,它有效地放在套筒和环之间,把力从套筒传到环,以响应套筒相对于环的向前运动,把刺激器表面压到皮肤表面上,刺激器表面的形状可压住皮肤切口周围的皮肤和身体组织的环形区,使切口鼓起和切口四周打开,由此把体液从切口压出。 A sampling device for collecting blood or interstitial fluid, the apparatus comprising: determining a longitudinal axis of the grip sleeve; adapted to support a skin puncturing tool holder generating an incision in the skin; protruding from the longitudinal front end of a sleeve relative to the sleeve and mounted for longitudinal movement of the ring, the ring having a front stimulator surface adapted to contact with the skin surface; and a force transmission member is elastically deformable, it is effectively placed between the sleeve and the ring, force is transmitted from the sleeve to the ring in response to forward movement of the sleeve relative to the ring, to press the stimulator surface of the skin surface, the stimulator surface shape can be pressed against the skin around the incision of the skin and body tissue annulus the incision to bulge and the sides of the incision to open, whereby body fluid is forced from the incision.
2. 2. 按照权利要求1的采样装置,其中,环构成一个内环,而装置还包括围绕着内环可伸缩的外环,外环从套筒向外突出,相对于套筒可作纵向运动;一个弹簧弹性地把外环向前偏压,外环相对于套筒和内环均可沿纵向运动。 The sampling device according to claim 1, wherein the ring constitutes an inner ring, and the apparatus further comprises an inner ring surrounding the outer telescopic, projecting outwardly from the outer sleeve, the sleeve may be made with respect to the longitudinal movement; a spring elastically biases the outer ring forwardly, the outer ring and the inner ring relative to the sleeve can be movable longitudinally.
3. 3. 按照权利要求2的采样装置,还包括一个装在套筒内相对于套筒作纵向运动的外壳,一个装在外壳内相对于外壳作纵向运动的撞击件,外壳和撞击件一起确定了一个锁定结构,把撞击件可释放地锁定在受弹簧偏压的击发准备状态,锁定结构可以释放,以响应外壳相对于套筒的向后运动。 The sampling device according to claim 2, further comprising a sleeve mounted in the housing with respect to the sleeve for longitudinal movement, a housing mounted in the housing for relative longitudinal movement of the impact member, the impact member and the housing together to determine a locking structure, the striking member is releasably locked in the cocked state by a spring biased locking structure may be released in response to rearward movement of the housing relative to the sleeve.
4. 4. 按照权利要求3的采样装置,还包括一个连接套,它用卡紧结合方式与环连接,用卡口式结合方式与外壳连接。 The sampling device according to claim 3, further comprising a connecting sleeve which in combination with a clamping ring connection manner, in combination with a bayonet manner connected to the housing.
5. 5. 按照权利要求1的采样装置,其中,刺激器表面相对于与轴线垂直的平面倾斜,倾斜是沿径向向内和沿纵向向后,相对于平面的倾斜角为10到65度。 The sampling device according to claim 1, wherein the surface of the stimulator with respect to a plane perpendicular to the axis is inclined, the inclination being radially inwardly and longitudinally rearwardly, the inclination relative to the plane angle of 10 to 65 degrees.
6. 6. 按照权利要求5的采样装置,其中,刺激器表面的宽度从约5mm到约20mm。 The sampling device according to claim 5, wherein the width of the stimulator surface is from about 5mm to about 20mm.
7. 7. 按照权利要求6的采样装置,其中,刺激器表面的内径不小于6.0mm左右。 The sampling device according to claim 6, wherein the inner diameter of the stimulator surface is no smaller than about 6.0mm.
8. 8. 按照权利要求7的采样装置,其中,内径不大于12.0mm左右。 Sampling device according to claim 7, wherein the inner diameter of no greater than about 12.0mm.
9. 9. 按照权利要求1的采样装置,其中,刺激器表面的宽度从约5mm到约20mm。 The sampling device according to claim 1, wherein the width of the stimulator surface is from about 5mm to about 20mm.
10. 10. 按照权利要求9的采样装置,其中,刺激器表面的内径从约6.0mm到约12.0mm。 The sampling device according to claim 9, wherein the inner diameter of the stimulator surface is from about 6.0mm to about 12.0mm.
11. 11. 按照权利要求1的采样装置,其中,刺激器表面的内径不小于6.0mm左右。 The sampling device according to claim 1, wherein the inner diameter of the stimulator surface is no smaller than about 6.0mm.
12. 12. 按照权利要求11的采样装置,其中,内径不大于12.0mm左右。 The sampling device according to claim 11, wherein the inner diameter of no greater than about 12.0mm.
13. 13. 按照权利要求1的采样装置,还包括一个装在套筒内并相对于套筒作纵向运动的外壳;一个装在外壳上并支承环和支座的连接套;一个装在外壳内的圈环;一个装在外壳内与圈环向后隔开的保持套;一个有效地位于保持套和圈环之间的击发准备弹簧;一个其后端与保持套连接的撞击件;一个把撞击件向前偏压到支座的撞击件弹簧;一个手动撞击件击发准备的按钮,它具有从外壳和套筒突出的可用手握的后端,和与圈环连接的前端;外壳上形成一个挡块,把撞击件可释放地锁定在击发准备状态。 The sampling device according to claim 1, further comprising a sleeve mounted within the housing and relative to the sleeve for longitudinal movement; mounted on the housing and a support ring and a connecting sleeve bearing; rings mounted within a housing ; and an annular ring mounted within the housing spaced rearwardly holding sleeve; effectively a spring cocked between the holding sleeve and the annular ring; striking a rear end thereof with the holding member connected to the sleeve; the impact member to a hammer spring biased to the front of the seat; a striking member of the firing button manually prepared, which has a front end connected to the housing and projecting from the rear end of the holding sleeve can be used, and an annular ring; forming a stop on the housing , the striking member is releasably locked in a cocked state.
14. 14. 按照权利要求13的采样装置,其中,环和连接套形成不用单独紧固件的第一连接;连接套和外壳形成不用单独紧固件的第二连接;外壳和套筒形成不用单独紧固件的第三连接;撞击件和保持套形成不用单独紧固件的第四连接;以及击发准备按钮和圈环形成不用单独紧固件的第五连接。 The sampling device according to claim 13, wherein the ring and the connecting sleeve forming a first connector without a separate fastener; connecting sleeve and a second connector housing is formed without a separate fastener; housing and the sleeve is formed without separate fasteners third connection; impingement sleeve and the holding member forming a fourth connector without a separate fastener; preparation and firing buttons and rings form a fifth connector without a separate fastener.
15. 15. 按照权利要求14的采样装置,其中,第一,第二,第三,第四和第五连接的每一个均为卡紧连接。 The sampling device according to claim 14, wherein the first, second, third, fourth, and fifth card are connected to each tight connection.
16. 16. 按照权利要求1的采样装置,与装在支座中的刺血针组合;在支座后面装在套筒内的定位件用于防止刺血针的向后运动。 The sampling device according to claim 1, the lancet holder is mounted in combination with; carrier mounted behind the positioning member within the sleeve for preventing rearward movement of the lancet.
17. 17. 一种采集血液或间质液的采样装置,装置包括:一个确定纵轴的可手握的套筒;以及一个从套筒纵向前端突出并相对于套筒作纵向运动的环,环具有一个适于与皮肤表面接触的前刺激器表面,其中,刺激器表面相对于与轴线垂直的平面倾斜,倾斜是沿径向向内和沿纵向向后,相对于平面的倾斜角为10到65度,刺激器表面的宽度从约5mm到约20mm,刺激器表面的内径不小于6.0mm左右。 A method of collecting blood or interstitial fluid sampling device, comprising: determining a longitudinal axis of the sleeve can be hand; and protrude from a distal end of the sleeve and longitudinally relative to the sleeve for longitudinal movement of the ring, with a suitable the front stimulator surface in contact with the skin surface, wherein the stimulator surface is inclined relative to a plane perpendicular to the axis, the inclination being radially inwardly and longitudinally rearwardly, the inclination relative to the plane angle of 10 to 65 degrees, the width of the stimulator surface is from about 5mm to about 20mm, an inner diameter of the stimulator surface is no smaller than about 6.0mm.
18. 18. 按照权利要求17的采样装置,还包括一个适于支承皮肤穿刺工具在皮肤上产生切口的支座。 The sampling device according to claim 17, further comprising a support adapted to support skin piercing tools create an incision in the skin.
19. 19. 一种采集血液或间质液的采样装置。 A blood sampling device or between interstitial fluid collection. 装置包括:一个确定纵轴的可手握的套筒;以及一个从套筒纵向前端突出并相对于套筒作纵向运动的环,环具有一个适于与皮肤表面接触的前刺激器表面,以及一个可弹性变形的传力件有效地放在套筒和环之间,把力从套筒传到环,以响应套筒相对于环的向前运动,把刺激器表面压到皮肤表面上,刺激器表面的形状可压住皮肤切口周围的皮肤和身体组织的环形区,使切口鼓起和切口四周打开,由此把体液从切口压出。 Apparatus comprising: determining a longitudinal axis of the sleeve can be hand; and a projection and the ring relative to the sleeve for longitudinal movement from the longitudinal front end of the sleeve, the ring having a front stimulator surface adapted to contact the skin surface, and an elastically deformable force-transmitting element disposed between the sleeve and the effective ring, the force is transmitted to the ring from the sleeve in response to forward movement of the sleeve relative to the ring, to press the stimulator surface skin surface, stimulator surface shape may be pressed against the skin surrounding the skin incision and the annular region of body tissue, so that the incision to bulge and the sides of the incision to open, whereby body fluid is forced from the incision.
20. 20. 按照权利要求19的采样装置,其中,刺激器表面相对于与轴线垂直的平面倾斜,倾斜是沿径向向内和沿纵向向后,相对于平面的倾斜角为10到65度, The sampling device according to claim 19, wherein the stimulator surface is inclined relative to a plane perpendicular to the axis, the inclination being radially inwardly and longitudinally rearwardly, the inclination relative to the plane angle of 10 to 65 degrees,
21. twenty one. 按照权利要求19的采样装置,其中,刺激器表面的宽度从约5mm到约20mm。 The sampling device according to claim 19, wherein the width of the stimulator surface is from about 5mm to about 20mm.
22. twenty two. 按照权利要求19的采样装置,其中,刺激器表面的内径不小于6.0mm左右。 The sampling device according to claim 19, wherein the inner diameter of the stimulator surface is no smaller than about 6.0mm.
23. twenty three. 按照权利要求19的采样装置,其中,刺激器表面相对于与轴线垂直的平面为倾斜,倾斜是沿径向向内和沿纵向向后,相对于平面的倾斜角为10到65度,刺激器表面的宽度从约5mm到约20mm,刺激器表面的内径不小于6.0mm左右。 The sampling device according to claim 19, wherein the surface of the stimulator with respect to a plane perpendicular to the axis is inclined, the inclination being radially inwardly and longitudinally rearwardly, the inclination relative to the plane angle of 10 to 65 degrees, the stimulator width of the surface from about 5mm to about 20mm, an inner diameter of the stimulator surface is no smaller than about 6.0mm.
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US5964718A (en) 1999-10-12

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